RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) reported third-quarter financial results and said it is preparing to submit a New Drug Application (NDA) for its lead candidate, lorundrostat, by late 2025 or early 2026. The move follows recent pre-NDA discussions with the FDA and marks a major milestone in the company’s pursuit of a new treatment for uncontrolled and resistant hypertension.
CEO Jon Congleton said the forthcoming submission will be supported by a comprehensive clinical package demonstrating a consistent safety and efficacy profile across multiple patient populations. “We are at an exciting point in our company’s history,” Congleton said, emphasizing the potential clinical impact of normalizing aldosterone production in hypertension and several related comorbidities.
OSA Trial Advances Toward Key Readout
Mineralys also completed enrollment in its Phase 2 Explore-OSA trial, which is assessing lorundrostat in overweight or obese patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. Topline results are expected in the first quarter of 2026. The company noted that positive findings would build on earlier success in its Explore-CKD study and help broaden lorundrostat’s potential reach.
An open-label extension of the Transform-HTN program remains ongoing, allowing patients continued access to lorundrostat while providing the company with longer-term safety and efficacy data.
Strengthened Cash Position Following Public Offering
Mineralys ended the quarter with $593.6 million in cash, cash equivalents, and investments — nearly tripling its year-end balance following a public equity financing that raised approximately $287.5 million in early September. Management said this capital will fund clinical and regulatory activities, along with corporate operations, into 2028.
R&D Costs Decline as Pivotal Program Winds Down
Research and development expenses dropped to $31.5 million for the quarter, down from $54 million a year ago. The decline reflects the completion of the lorundrostat pivotal program earlier in 2025, though increased hiring and manufacturing-related spending offset part of that decrease. General and administrative costs rose to $9.7 million, driven by higher personnel expenses and professional fees.
Total other income improved slightly to $4.2 million, driven by higher interest earnings on an expanded investment portfolio. Net loss narrowed to $36.9 million from $56.3 million in the same period last year.
With its NDA submission approaching and additional Phase 2 data on the horizon, Mineralys enters 2026 with significant financial flexibility and a clear regulatory path for lorundrostat — a potential new option in a hypertension market long in need of novel mechanisms.
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